Chronic Stable AnginaPhase 4MIDANCT03486561
Management of Ischemic Heart Disease With Angiwell-XR (Ranolazine)
A Phase 4 study testing Ranolazine in people with Chronic Stable Angina, run by OBS Pakistan.
Trial summary
The rationale of MIDA trial is to determine efficacy and tolerability of ranolazine molecule among Pakistan population and obtain firsthand knowledge about the molecule ranolazine. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chronic Stable Angina
- What is being tested?
- Ranolazine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2018to 31 Oct 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with diagnosis of coronary artery disease (CAD)
- Patients present with the symptoms of stable angina after withdrawn from other antianginal drugs and given the required background therapy for at least 7 days will be qualified for entering this study and performing 1st ETT qualifying test
- Patients developed exercise-induced ECG ischemiai during two qualifying exercise treadmill testsii.
- Willing and able to provide a written informed consent
Who cannot join
- • Factors that might compromise ECG or ETT interpretation
- Patients with resting ST-segment depression ≥ 1mm in any lead
- Left bundle-branch block
- Patients implanted with pacemaker
- Patients under Digitalis therapy
- Patients with family history of (or congenital) long QT syndrome
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- Patients with congenital heart disease
- Patients with uncorrected valvular heart disease
- Patients with unstable angina, or MI, or coronary revascularization procedure ≤ 2 months prior enter this study
- Female who is pregnant/lactating or planning to be pregnant, or female of childbearing potential* who is not using medically recognized method of contraception
- *Other than those who have been surgically sterilized (defined as having undergone hysterectomy or bilateral oophorectomy or bilateral salpingectomy; tubal ligation alone is not considered sufficient) or one year post-menopausal.
- Patients are under any one of the following conditions:
- New York Heart Association (NYHA) Class III or Class IV congestive heart failure (CHF)
- QTc > 450 msec at screening
- Active myocarditis, pericarditis, hypertrophic cardiomyopathy
- Uncontrolled hypertension (defined as SBP > 180 mmHg) Voltage criteria for left ventricular hypertrophy in the absence of repolarization abnormalities will not be exclusion criteria
- Use of any investigational product ≤ 4 weeks prior to screening
- Patients with severe hepatic disease (e.g., liver cirrhosis)
- Patients with impaired renal function (defined as serum Cr >1.5 mg/dl)
- Patients with any condition or disease which is considered not suitable for this study by investigator
Trial locations and contacts
No sites are listed yet.
About this study
The rationale of MIDA trial is to determine efficacy and tolerability of ranolazine molecule among Pakistan population and obtain firsthand knowledge about the molecule ranolazine.
- Conditions
- Chronic Stable Angina
- Being tested
- Ranolazine
- Keywords
- Ranolazine, Pakistan, Ischemic Heart Disease
- Medical subject headings
- Angina, Stable, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanolazineDrug
Ranolazine inhibits sodium and potassium ion channel currents. Inhibition of the late phase of the inward sodium current during cardiac repolarization has been well studied4. In disease states, enhanced sodium-calcium exchange due to augmented late phase of the inward sodium current activity leads to increased cytosolic calcium concentration. Intracellular calcium overload is believed to be critical to the mechanism of decreased left ventricular relaxation caused by ischemia and reperfusion. Elevated left ventricular diastolic wall tension compromises myocardial blood flow even further.
| Study group | Role | What they receive |
|---|---|---|
| Ranolazine | Other | Ranolazine was approved by the U.S. Food and Drug Administration in 2006 in 500 mg and 1000 mg extended-release doses, advising 500 mg BID as a starting dose and 1000 mg BID as maximum dose Receives: Drug: Ranolazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Reduction in frequency of Angina with Ranolazine
To determine reduction in frequency of Angina with Ranolazine
Measured: 24 weeks
Secondary outcomes (1)
Safety: Proportion of participants experiencing an adverse event (AE)
Proportion of participants experiencing an adverse event (AE)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2018
- Study start1 Apr 2018 (estimated)
- Primary completion30 Sep 2018 (estimated)
- Study completion31 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Stable AnginaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open Labelled Phase IV clinical trial
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OBS Pakistan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03486561
- Sponsor's protocol ID
- MIDA-OBS-001
- Acronym
- MIDA
- Status last verified
- Mar 2018
- First submitted
- 15 Mar 2018
- Last updated
- 3 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Ischemic Heart Disease With Angiwell-XR (Ranolazine)
- ClinicalTrials.gov ID
- NCT03486561
- Acronym / sponsor ID
- MIDA / MIDA-OBS-001
- Conditions
- Chronic Stable Angina
- Keywords
- Ranolazine, Pakistan, Ischemic Heart Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- OBS PakistanIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2018 (estimated)
- Primary completion
- 30 Sep 2018 (estimated)
- Study completion
- 31 Oct 2018 (estimated)
- First posted
- 3 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The rationale of MIDA trial is to determine efficacy and tolerability of ranolazine molecule among Pakistan population and obtain firsthand knowledge about the molecule ranolazine.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open Labelled Phase IV clinical trial
| Arm | Type | Receives |
|---|---|---|
| Ranolazine | Other | Drug: RanolazineRanolazine was approved by the U.S. Food and Drug Administration in 2006 in 500 mg and 1000 mg extended-release doses, advising 500 mg BID as a starting dose and 1000 mg BID as maximum dose |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with diagnosis of coronary artery disease (CAD)
Key exclusion criteria (20 listed)
- • Factors that might compromise ECG or ETT interpretation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RanolazineRanolazine inhibits sodium and potassium ion channel currents. Inhibition of the late phase of the inward sodium current during cardiac repolarization has been well studied4. In disease states, enhanced sodium-calcium exchange due to augmented late phase of the inward sodium current activity leads to increased cytosolic calcium concentration. Intracellular calcium overload is believed to be critical to the mechanism of decreased left ventricular relaxation caused by ischemia and reperfusion. Elevated left ventricular diastolic wall tension compromises myocardial blood flow even further. | Drug | Ranolazine |
Primary outcome
Efficacy: Reduction in frequency of Angina with Ranolazine
Time frame: 24 weeks
To determine reduction in frequency of Angina with Ranolazine
1 secondary outcome
Safety: Proportion of participants experiencing an adverse event (AE)
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ranolazine in people with Chronic Stable Angina, run by OBS Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Faizan Shaukat (+923328814816, faizan.shaukat@obs.com.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy: Reduction in frequency of Angina with Ranolazine (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2018.